Quality Systems Services, LLC’s Post

📣 ICYMI: Our May blog post is up on the website. This month, we share why you should use publicly available data to prepare for an FDA Inspection. 🔍 The data is out there, let's use it and learn from it. https://wix.to/PadqUjC #newblogpost #qualitysystems #quality #pharma

𝗙𝗗𝗔 𝗚𝘂𝗶𝗱𝗮𝗻𝗰𝗲: 𝗥𝗲𝗴𝗶𝗼𝗻𝗮𝗹 𝗜𝗺𝗽𝗹𝗲𝗺𝗲𝗻𝘁𝗮𝘁𝗶𝗼𝗻 𝗚𝘂𝗶𝗱𝗲 𝗳𝗼𝗿 𝗘𝟮𝗕 (𝗥𝟯) 𝗲-𝗧𝗿𝗮𝗻𝘀𝗺𝗶𝘀𝘀𝗶𝗼𝗻 𝗼𝗳 𝗜𝗖𝗦𝗥 𝗮𝗻𝗱 𝗣𝗿𝗼𝘃𝗶𝗱𝗶𝗻𝗴 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗦𝘂𝗯𝗺𝗶𝘀𝘀𝗶𝗼𝗻𝘀 𝗶𝗻 𝗘𝗹𝗲𝗰𝘁𝗿𝗼𝗻𝗶𝗰 𝗙𝗼𝗿𝗺𝗮𝘁: 𝗜𝗡𝗗 𝗦𝗮𝗳𝗲𝘁𝘆 𝗥𝗲𝗽𝗼𝗿𝘁𝘀 Guidance: https://lnkd.in/eKPngD7b This FDA guide explains how to electronically submit reports on side effects of various medications to the FDA. It covers a broad range of drugs, including prescription and over-the-counter medications, as well as biological products. Beyond specifying what to report, the guide focuses on the technical aspects of electronic submissions, ensuring consistent formatting and data collection that meets the FDA's specific requirements. This streamlined process allows healthcare providers, researchers, and even patients to contribute to the FDA's database on medication safety. Contact  BIOBOSTON CONSULTING today or visit our  website to learn more about how we can support your organization. #pharmaceuticals #biotechnology #medicaldevices #consulting #fda  #quality #compliance #qualityassurance #regulatoryaffairs

Unlocking the Power of Statistical Insights in Pharmaceutical Quality: Join us for the 3rd Edition of Statistics for Quality Control and Quality Assurance Practice led by renowned expert Dr. Joachim Ermer. Discover the latest advancements in analytical procedure development and gain essential skills to ensure compliance with regulatory standards. 📩 Limited seats available! Reach out now at booking@metamorphglobal.io or call us at +1 657 452 8174. Registration link - https://lnkd.in/gb_g9G73 #PharmaceuticalQuality #StatisticalAnalysis #QualityAssurance #QualityControl #ICHGuidelines #AnalyticalProcedures

The CVSS Modules AI Brain sets new benchmarks for quality assurance in #PharmaceuticalManufacturing, making it the ideal companion for pharma and FDA compliance. Compliance, integrity, and precision are paramount in the pharmaceutical industry. Our AI system conducts comprehensive compliance audits, meticulously inspecting every aspect of the manufacturing process to ensure adherence to regulatory standards. From vial to tube, integrity checks to label inspections, the #AIBrain maintains strict quality control, guaranteeing the safety and efficacy of every product that leaves the facility. Futhermore, it helps to regulate the speed at which humans interact with and inspect products themselves, and prevent unsafe practices. Interested in learning more? Visit our website to get in contact with a specialist. https://lnkd.in/gGmCND4g #CVSSModules #PharmaCompliance #ManufacturingSafety #PharmaceuticalIndustry #PharmaManufacturing #AIIndustrialVision #QualityAssurance #AdvancedMonitoring #ProductionInsights #ManufacturingAutomation #ComplianceAudit #AIIntegration #QualityControl

📌 𝗘𝘀𝘀𝗲𝗻𝘁𝗶𝗮𝗹 𝗗𝗿𝘂𝗴 𝗗𝗲𝗹𝗶𝘃𝗲𝗿𝘆 𝗢𝘂𝘁𝗽𝘂𝘁𝘀 (𝗘𝗗𝗗𝗢𝘀): 𝗔 𝗩𝗶𝘀𝘂𝗮𝗹 𝗦𝘂𝗺𝗺𝗮𝗿𝘆 The FDA draft guidance "𝗘𝘀𝘀𝗲𝗻𝘁𝗶𝗮𝗹 𝗗𝗿𝘂𝗴 𝗗𝗲𝗹𝗶𝘃𝗲𝗿𝘆 𝗢𝘂𝘁𝗽𝘂𝘁𝘀 𝗳𝗼𝗿 𝗗𝗲𝘃𝗶𝗰𝗲𝘀 𝗜𝗻𝘁𝗲𝗻𝗱𝗲𝗱 𝘁𝗼 𝗗𝗲𝗹𝗶𝘃𝗲𝗿 𝗗𝗿𝘂𝗴𝘀 𝗮𝗻𝗱 𝗕𝗶𝗼𝗹𝗼𝗴𝗶𝗰𝗮𝗹 𝗣𝗿𝗼𝗱𝘂𝗰𝘁𝘀" https://lnkd.in/eAQSXMmR is an excellent guide providing comprehensive insights on essential drug delivery outputs sometimes referred to as Essential Performance Requirements EPTs for devices intended to deliver drugs and biological products. The reader is guided through the 𝗜𝗱𝗲𝗻𝘁𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻, 𝗖𝗼𝗻𝘁𝗿𝗼𝗹 and 𝗠𝗮𝗶𝗻𝘁𝗲𝗻𝗮𝗻𝗰𝗲 of 𝗘𝗗𝗗𝗢s throughout the device lifecycle. 𝗧𝗵𝗮𝗻𝗸 𝘆𝗼𝘂 🙏 for 𝘆𝗼𝘂𝗿 time and please 𝗟𝗶𝗸𝗲 👍, 𝗦𝗵𝗮𝗿𝗲, and/or 𝗖𝗼𝗺𝗺𝗲𝗻𝘁 For all inputs, feedback, improvements and questions I will be most grateful. #medicaldevices #invitrodiagnostics #combinationproducts #mlv #qualityassurance #regulatoryaffairs #pharmaceuticals 

Pre-Approval Inspection (PAI) Services Pre-approval Inspections are one of the most critical inspections any Biologic, Pharmaceutical or Medical Device firm will undertake. Failure to meet FDA expectations can have a huge impacts: - Delays to product launch - Remediation costs ($Ms) - Lost market share - Loss of credibility We ensure that every step towards Inspection Readiness is carefully calibrated to your needs. Our method is backed by tangible tools and training programs developed from the ground up, tailored not just to your product, but to your organization's unique scale and scope. This approach allows you to maintain focus on running your business, while we dedicate ourselves fully to your Inspection Readiness.. PAI readiness is critical, and ProPharma is an industry leader in providing PAI Readiness to our clients. To date, we have had a 100% success rate on our PAI Readiness projects. Get in touch to learn more! #PAI, #PreApprovalInspection #inspectionreadiness #regulatory https://lnkd.in/dZQER4-W

🔍 Looking for a comprehensive guide on handling Corrective and Preventive Actions (CAPA) in the pharmaceutical and medical industries? 🏥 Download our FREE SOP for CAPA procedure now! 📝 🔗 Access this valuable resource in our Pharma and Medical Resources courses and events group! Join us today to stay updated on the latest industry insights and best practices. 💡 https://lnkd.in/eUXFKGY2 👉 Don't miss out on engaging discussions and expert advice in our Pharmatalks Telegram Community! Click the link below to join: 👇👇👇👇👇👇👇 https://lnkd.in/eGYnkHeM 💊🌟 #Pharma #Medical #CAPA #SOP #PharmaceuticalExcellence

🔍 Looking for a comprehensive guide on handling Corrective and Preventive Actions (CAPA) in the pharmaceutical and medical industries? 🏥 Download our FREE SOP for CAPA procedure now! 📝 🔗 Access this valuable resource in our Pharma and Medical Resources courses and events group! Join us today to stay updated on the latest industry insights and best practices. 💡 https://lnkd.in/eUXFKGY2 👉 Don't miss out on engaging discussions and expert advice in our Pharmatalks Telegram Community! Click the link below to join: 👇👇👇👇👇👇👇 https://lnkd.in/eGYnkHeM 💊🌟 #Pharma #Medical #CAPA #SOP #PharmaceuticalExcellence